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NCT05359445

PHASE1

IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

Sponsor: Immatics Biotechnologies GmbH

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed. Primary objective: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab Secondary objectives: * To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab * To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab * To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab

Official title: A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), as Monotherapy or in Combination With Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-05-19

Completion Date

2029-12

Last Updated

2025-09-09

Healthy Volunteers

Conditions

Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer

Interventions

BIOLOGICAL

IMA401 (Phase Ia)

Intravenous infusions in escalating dose levels

BIOLOGICAL

Pembrolizumab (Phase Ia)

Intravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab

BIOLOGICAL

IMA 401 (Phase Ib)

Treatment at recommended dose for extension (RDE)

Inclusion Criteria: * Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures * Patients ≥ 18 years old * Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered * Confirmed HLA status and IMA401 tumor target MAGE-A4 and/or MAGE-A8 expression * Life expectancy \> 2 months * ECOG Performance Status of 0 to 1 * Measurable disease according to RECIST 1.1 * Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status * Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy Exclusion Criteria: * Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) * History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab * Patients with prior allogeneic stem cell transplantation or organ transplantation * Patients with autoimmune diseases needing disease-directed treatment * Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results * Positive for HIV or with active hepatitis B or C infection. * Patients with active infection * Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment * Patients with active central nervous system metastases and leptomeningeal metastases

Locations (23)

Universitaetsklinikum Freiburg, Zentralklinikum, Klinik fuer Innere Medizin I

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitaetsklinikum Heidelberg AöR, Nationales Zentrum fuer Tumorkrankheiten

Heidelberg, Baden-Wurttemberg, Germany

Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen AöR, Comprehensive Cancer Center Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm AöR, ECTU-Early clinical Trials Unit Universitaetsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen AöR, Interdisciplinary Clinical Trial Unit with ECTU

Erlangen, Bavaria, Germany

Klinikum rechts der Isar der TU Muenchen AöR, Klinik und Poliklinik fuer Innere Medizin III

Munich, Bavaria, Germany

Klinikum Nuernberg, Klinik fuer Innere Medizin 5, Abteilung Onkologie/Haematologie

Nuremberg, Bavaria, Germany

Universitaetsklinikum Regensburg AöR, Klinik fuer Innere Medizin 3

Regensburg, Bavaria, Germany

Universitaetsklinikum Wuerzburg AöR, Interdisziplinaeres Studienzentrum mit ECTU

Würzburg, Bavaria, Germany

Goethe Universitaetsklinikum Frankfurt AöR, Medizinische Klinik II

Frankfurt am Main, Hesse, Germany

Sana Klinikum Offenbach GmbH, Klinik für Pneumologie/ Thoraxzentrum Rhein-Main

Offenbach, Hesse, Germany

Universitätsmedizin Göttingen, Klinik für Hämatologie und Onkologie

Göttingen, Lower Saxony, Germany

Medizinische Hochschule Hannover, Klinik fuer Haematologie, Haemostaseologie, Onkologie und Stammzelltransplantation

Hanover, Lower Saxony, Germany

Universitätsklinikum Bonn AöR, Medizinische Klinik IIII

Bonn, North Rhine-Westphalia, Germany

Marien Hospital Duesseldorf GmbH, Klinik fuer Onkologie/Haematologie und Palliativmedizin

Düsseldorf, North Rhine-Westphalia, Germany

Universitaetsklinikum Muenster AöR, Medizinische Klinik A

Münster, North Rhine-Westphalia, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, III. Medizinische Klinik

Mainz, Rhineland-Palatinate, Germany

Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III

Chemnitz, Saxony, Germany

Universitaetsklinikum C. - G. - Carus Dresden, Technische Universitaet Dresden AöR, NCT/UCC Early Clinical Trial Unit

Dresden, Saxony, Germany

Universitaet Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)

Leipzig, Saxony, Germany

Universitaetsklinikum Schleswig- Holstein, Campus Kiel, Medizinische Klinik II Haematologie und Onkologie, Karl-Lennert Tumorzentrum

Kiel, Schleswig-Holstein, Germany

Charité Universitaetsmedizin Berlin KöR, Klinik fuer Haematologie und Onkologie

Berlin, Germany

Clinical Research Directory

IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (23)